Actively Recruiting

Phase Not Applicable
Age: 14Years - 19Years
FEMALE
Healthy Volunteers
ID06147973

Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Led by Drexel University · Updated on 2024-04-10

148

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating cardiovascular disease risk in adolescent girls aged 14 to 19 who have overweight or obesity. This study compares an acceptance-based healthy lifestyle intervention (ABT) to a health education (HE) intervention to see which better promotes weight loss and improvements in physiological, health-related, and psychological factors. The study focuses on girls from diverse racial and ethnic backgrounds and aims to test the effectiveness of ABT tailored specifically for this group. Participants will be randomly assigned to one of two groups. The ABT group will attend 18 group sessions lasting 90 minutes each over 6 months, combining in-person and remote meetings. The HE group will attend nine 75-minute group sessions with health education handouts over the same period. Both interventions are delivered by trained weight loss coaches using a hybrid model in an outpatient community clinic. During the 18-month study, participants will complete assessments at the start, mid-treatment (3 months), end of treatment (6 months), and follow-ups at 12 and 18 months. Assessments include questionnaires, measurements of weight, height, body composition, blood pressure, blood lipids, and wearing smart watches to track sleep and physical activity. Researchers will monitor changes in BMI z-score as the primary outcome and evaluate physiological, behavioral, and psychological health factors to understand the interventions' impact and safety.

CONDITIONS

Brief Title

An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Who Can Participate

Age: 14Years - 19Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 14 to 19 years
  • Identify as female
  • BMI at or above the 85th percentile for sex and age
Not Eligible

You will not qualify if you...

  • Lost 5% or more of body weight in the past 6 months for reasons other than post-partum
  • Begun or changed dosage of medications affecting appetite or body composition in the past 3 months
  • Plans to move out of the area within one year
  • Active cancer or cancer treatment in the past 2 years (except non-melanoma skin cancer)
  • Active or chronic infections such as HIV or tuberculosis
  • Active cardiovascular disease or heart treatment in past 6 months
  • Active kidney disease
  • History of bariatric surgery
  • Lung disease requiring oxygen (e.g., emphysema, chronic bronchitis)
  • Diagnosed diabetes (type 1 or 2)
  • Any condition preventing physical activity
  • Diagnosis of an eating disorder
  • Severe mental health conditions limiting participation (e.g., severe depression, psychotic disorder)
  • Recent or ongoing drug or alcohol abuse
  • Currently pregnant or less than 3 months post-partum
  • Expecting possible pregnancy within the next year
  • Unwillingness to report possible or confirmed pregnancies during the trial period

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive either an acceptance-based behavioral intervention or health education to promote weight loss and healthy lifestyle changes.

18 group sessions of 90 minutes each for ABT or 9 group sessions of 75 minutes each for HE, delivered in a hybrid of in-person and remote formats

Follow-up

Duration - 12 months

Participants are assessed for ongoing physiological, behavioral, and psychological outcomes after treatment ends.

Assessments at 6, 12, and 18 months from baseline

Trial Site Locations

Total: 1 location

1

Drexel University

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

S

Stephanie Manasse, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014.

Cynthia L Ogden, Margaret D Carroll, Hannah G Lawman...

https://pubmed.ncbi.nlm.nih.gov/27272581

Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity.

Faith A Newsome, Michelle I Cardel, Xiaofei Chi...

https://pubmed.ncbi.nlm.nih.gov/36394498